On-Demand Complimentary Webinar

Structured Exploration of Clinical Trial Data

Session 2: Complex Innovative Designs

Session Chair(s)

Representative Invited

FDA, United States

Amy Xia, PhD

Executive Director, Biostatistics

Amgen Inc., United States

Both the 21st Century Cures Act and the PDUFA VI legislations emphasize on complex innovative designs, which require simulations to understand the design operating characteristics, statistical properties, and operational features. This session will review and discuss the issues related to any complex trial design that we need to simulate the trial to understand its full behavior. Additionally, it will discuss analyses that are complex enough so that we likely need simulation for deeper understanding of the models. Examples of complex analyses include using hierarchical analyses and historical data will be given. A group of speakers and panelists will discuss opportunities and challenges relative to complex innovative designs and analyses in medical product development.

Learning Objective : At the conclusion of this session, participants should be able to:

Discuss the role of simulation in complex innovative designs and analyses

Discuss case studies in complex innovative designs and analyses

Describe challenges and opportunities in complex innovative designs and analyses

Speaker(s)

Speaker

Representative Invited

FDA, United States

Speaker

Gregory Levin, PhD

Mathematical Statistician, Office of Translational Sciences, CDER

FDA, United States

Speaker

Scott M Berry, PhD

President and Senior Statistical Scientist

Berry Consultants LLC, United States

Speaker

Brian Hobbs, PhD

Associate Staff of Quantitative Health Sciences, The Section Head of C